Monoclonal antibodies are often formulated in liquid and their stability over time is established by extensive characterization studies.  This requires a large number of formulations to be screened and evaluated by their ability to minimize chemical changes, fragmentation and aggregation of the product during stability studies in which degradation is accelerated, typically by heat or agitation. In this work we developed a high throughput formulation platform for determining protein stability in a range of formulations in 96 well plates. The formulations are prepared on the plate by adding protein to concentrated buffers. This method eliminates dialysis of protein in each formulation buffer. The formulations cover a range of buffers, pH, sodium chloride concentrations and excipients.  The use of low sample volumes allows early formulation studies to be completed with less material. The use of high precision assays (SE-UPLC, DSF, turbidity and extrinsic fluorescence) allows significant changes in aggregation to be detected within one month at 37�C.  Comparison of the data generated by the screening method with real time stability is used to evaluate the utility of the screening method.

Development of a high throughput formulation platform for monoclonal antibodies

247th National Meeting (2014)

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